GUDIDData
gudid Primary ID: 8004CB-NA

Nonin (UDI 8004CB-NA)

Manufactured by NONIN MEDICAL, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Nonin - Primary ID 8004CB-NA

Device Regulatory Overview

The Nonin (Model/Catalog Number: 8004CB-NA) is a medical device manufactured by NONIN MEDICAL, INC.. This product is indexed under FDA Product Code / Category Classification MUD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
8004CB-NA
Product Code / EMDN
MUD
Device Name
Non-Adhesive, Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX Technology
Database Sync Date
2026-08-09 09:35:45

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Nonin?

The registered manufacturer of record for Nonin is NONIN MEDICAL, INC..

What is the Primary UDI-DI identifier for Nonin?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8004CB-NA.

What classification code is assigned to this device?

This device is registered under product classification code MUD.

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